Temporomandibular Disorder
Conditions
Brief summary
Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point. Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection
Interventions
OTHERComputer guided sodium hyaluronate injections
Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space
OTHERconventional sodiumhyaluronate injections
Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patients diagnosed with internal derangement according to Wilkins stage I and II. * Patients who would not respond to conservative treatment as a first line of treatment.
Exclusion criteria
* Patients with Wilkins stage III, IV, V. * History of mandibular fracture. * Lactating, pregnant or planning pregnancy women. * Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TMJ dysfunction | Baseline, 1 month, and 3 months | A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows: * Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors. * Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if \<2 mm, score 1 - if 2-5 mm, and score 5 - if \>5 mm |
| change in pain score | Baseline,1 months, and 3 months | Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 (0 is pain-free and 10 is severe intolerable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of operation | Baseline | Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure. |
| Number of Needle Relocation | Baseline | The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis. |
Countries
Egypt
Outcome results
None listed